INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Medical Devices
FEI: FEI-3895D13A
🛡️ LEVEL 0 · PAPER REGISTRATION ONLY
Boston Scientific Cork, Ltd.
Registered Address: Boston Scientific Limited, Business And Technology Park, Model Farm Road, Cork, US (Ireland)
For Brand Buyers: Boston Scientific Cork, Ltd. carries a CCC (12/100) rating due to documented FDA activity centered on cGMP documentation controls. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (1): openFDA Enforcement Reports
· Resolved Name Aliases: Boston Scientific Cork, Ltd.
CCC
12/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 93% of tracked Medical Devices facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
CCC (12/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 0 / 4
Registered in FDA Database — Zero Physical FDA Inspections Recorded
Dim 4 · 'Elsa' Audit Odds
83%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
4%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
5 Brands
~23 Downstream SKUs
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT
Tailored to FEI FEI-3895D13A's FDA Record
5 Questions to Ask Boston Scientific Cork, Ltd. Before Signing a Manufacturing Contract
Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:
- Q1: Regarding Recall Z-0232-2027 (Class II on 2026-10-28), what line-clearance or preventive control changes were implemented to prevent recurrence?
- Q2: Since FDA databases show an electronic registration without a recorded physical FDA inspection, can you provide your most recent third-party SQF, UL, NSF, or ISO cGMP audit report?
- Q3: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
- Q4: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI FEI-3895D13A?
- Q5: Can we review a redacted Master Manufacturing Record (MMR) and Batch Production Record (BPR) with dual-operator weight verification and yield reconciliation?
Cross-Database Regulatory & Inspection Timeline
Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.
FDA Enforcement Recall (Class II · Z-0232-2027) · 2026-10-28
View Recall Notice →
Product: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290
Reason: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
FDA Enforcement Recall (Class II · Z-0243-2027) · 2026-10-28
View Recall Notice →
Product: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440
Reason: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
FDA Enforcement Recall (Class II · Z-0258-2027) · 2026-10-28
View Recall Notice →
Product: Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750
Reason: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
FDA Enforcement Recall (Class II · Z-0231-2027) · 2026-10-28
View Recall Notice →
Product: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280
Reason: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
FDA Enforcement Recall (Class II · Z-0229-2027) · 2026-10-28
View Recall Notice →
Product: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
Reason: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
FDA Enforcement Recall (Class II · Z-0260-2027) · 2026-10-28
View Recall Notice →
Product: Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840
Reason: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
FDA Enforcement Recall (Class II · Z-0227-2027) · 2026-10-28
View Recall Notice →
Product: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240
Reason: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
FDA Enforcement Recall (Class II · Z-0237-2027) · 2026-10-28
View Recall Notice →
Product: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340
Reason: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
FDA Enforcement Recall (Class II · Z-0259-2027) · 2026-10-28
View Recall Notice →
Product: Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810
Reason: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
FDA Enforcement Recall (Class II · Z-0233-2027) · 2026-10-28
View Recall Notice →
Product: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300
Reason: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Manufacturer Right-of-Reply & Free Match Correction
GUARDRAIL PROTECTEDTo ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.
Dimension 3 · FDA 6-System Model
6-Subsystem cGMP Radar Breakdown
Sub-scores mapped across FDA's six core inspection subsystems.
Quality System (CAPA & OOS)
15/100
Materials & Incoming Identity
13/100
Production & Batch Records
14/100
Facilities, Sanitation & Pest
16/100
Laboratory & Stability Controls
13/100
Packaging & Allergen Labeling
17/100
Layer 6 · Clean-Record Sourcing Alternatives
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Grade AAA · 99/100 Clean Record
Score Provenance Receipts
Every point in this facility's FDA Record Index (12/100) is backed by a linked government record (36-month half-life decay).
| Event | Date | Weight | Receipt |
|---|---|---|---|
| Recall (Class II) | 2026-10-28 | -12.0 pts | Z-0232-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | Z-0243-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | Z-0258-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | Z-0231-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | Z-0229-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | Z-0260-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | Z-0227-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | Z-0237-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | Z-0259-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | Z-0233-2027 ↗ |