Medtronic Neuromodulation recalls InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
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…
Read the official notice →- Date
- 2026-10-28
- Country
- United States
- Brand
- Medtronic Neuromodulation
- Product
- InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and territory of Puerto Rico. The…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medtronic Neuromodulation recalls
- 2026-06-03
Medtronic Neuromodulation recalls Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and The countries of Austria, France,…Official notice →- 2026-05-20
Medtronic Neuromodulation recalls Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG…
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare…
- 2026-01-21
Medtronic Neuromodulation recalls A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and…
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
- 2025-12-31
Medtronic Neuromodulation recalls Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN…
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Argentina, Aruba,…Official notice →- 2025-05-07
Medtronic Neuromodulation recalls Enhanced Verify Evaluation Handset (CFN HH90130FA)
Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered…
FDA · DeviceMedtronic NeuromodulationUS Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL,…Official notice →- 2025-04-16
Medtronic Neuromodulation recalls Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model…
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
FDA · DeviceMedtronic NeuromodulationWorldwide Distribution: US (Nationwide) and OUS (Global) to countries of:…Official notice →
Other drugs & medical recalls in the United States
- 2026-10-28
AVID Medical, Inc. recalls Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
Medline Industries, LP recalls MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit…
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
FDA · DeviceMedline Industries, LPWorldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.Official notice →Solstice Corporation recalls Xact mole marker for mammography Model/Catalog Number: M15RM
The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
FDA · DeviceSolstice CorporationWorldwide - US Nationwide distribution in the states and territory of CA, FL,…Official notice →Medtronic MiniMed, Inc. recalls Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version:…
A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - U.S. Nationwide distribution in the states of AL, CA, CT, FL, LA,…Official notice →restor3d Inc. recalls Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description:…
Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
FDA · Devicerestor3d Inc.U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.Official notice →Boston Scientific Cork, Ltd. recalls Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290
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…
FDA · DeviceBoston Scientific Cork, Ltd.Worldwide distribution US Nationwide and territory of Puerto Rico. The…Official notice →