CC0 PUBLIC RECORD GRAPH Every score & timeline item links directly to its underlying U.S. FDA record (openFDA, ORA FOIA Reading Room, DECRS & OASIS).
FG
GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Recalls → Z-0267-2027
Class II Recall · Z-0267-2027 Report Date: 2026-10-28 · Status: Ongoing

Medtronic Neuromodulation — Medical Devices Recall

Product Description: InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Reason for Recall: Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.
Distribution Pattern: Worldwide distribution - US Nationwide and territory of Puerto Rico. The countries of Brazil, Colombia, Chile, Canada, Japan, New Zealand, Australia, United Kingdom, Switzerland, S