Boston Scientific Neuromodulation Corporation recalls Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper…
Read the official notice →- Date
- 2022-11-23
- Country
- United States
- Brand
- Boston Scientific Neuromodulation
- Product
- Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
- Classification
- Class II
- Units
- U.S Nationwide Distribution including states of: AL, AR, AZ, CA, CO, CT, FL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Boston Scientific Neuromodulation recalls
- 2025-09-24
USBoston Scientific Neuromodulation Corporation recalls Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device…
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide - US Nationwide distribution including in the states of MN, FL, CO,…Official notice →- 2025-09-10
- US
Boston Scientific Neuromodulation Corporation recalls Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect…
As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and…
FDA · DeviceBoston Scientific Neuromodulation CorporationU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice → - 2025-08-27
- US
Boston Scientific Neuromodulation Corporation recalls Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep…
Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural…
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide - US Nationwide distribution including in the states of MN, FL, CO,…Official notice → - 2024-08-21
- US
Boston Scientific Neuromodulation Corporation recalls WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may…
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC,…Official notice → - 2024-06-05
- US
Boston Scientific Neuromodulation Corporation recalls Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32…
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients…
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide - US Nationwide distribution including in the states of TX, WA, MT,…Official notice → - 2023-06-21
- US
Boston Scientific Neuromodulation Corporation recalls Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion…
Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver…
FDA · DeviceBoston Scientific Neuromodulation CorporationUS Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK,…Official notice →
Other drugs & medical recalls in the United States
- 2022-11-23
- US
Sonendo Inc recalls GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Procedure Instruments with erroneous unit carton labels.
FDA · DeviceSonendo IncWorldwide - U.S. Nationwide distribution in the state of OH and the country of…Official notice → - US
Becton Dickinson & Co. recalls BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative…
Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false…
- US
Baxter Healthcare Corporation recalls Hill-Rom Progressa Bed System
The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur…
FDA · DeviceBaxter Healthcare CorporationWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI,…Official notice → - US
DeVilbiss Healthcare LLC recalls 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
FDA · DeviceDeVilbiss Healthcare LLCUS Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and…Official notice → - US
LeMaitre Vascular, Inc. recalls TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire…
Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole,…
FDA · DeviceLeMaitre Vascular, Inc.No US distribution. Foreign distribution to United Kingdom, Germany, France,…Official notice → - US