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Superion recallZ-0230-2023 · Boston Scientific Neuromodulation Corporation · initiated Oct 12, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Neuromodulation Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 deployment of the device during implantation.

FDA root cause category: Process change control

What the company is doing

On 10/12/2022, the firm, Boston Scientific, sent an "Urgent: Medical Device Recall" letter via FedEx to customers. The letter described the product, problem and actions to be taken. The Customers are instructed to: -Review their facility's device inventory: Segregate and return any unused Superion IDS devices from the affected subset to Boston Scientific. Complete and return account-specific Reply Verification Tracking Form via Email: [email protected] or Fax to: Field Action Center at 1-763-415-7708. -Patient follow-up: Discuss this advisory with their patient(s) who are implanted with an affected device. Promptly investigate any reported pain and/or discomfort, or any suspected indication of migration of the Superion IDS implant, which may suggest a potential spindle cap weld break. If an affected device remains implanted in their patient, and successful deployment and/or device structural integrity is questioned, consider confirming via imaging. -If a spindle cap weld break is confirmed post-implant: Assess the clinical benefits versus risks associated with explanting an affected Superion IDS from their patient. Note that the Superion IDS Inserter tool would be unable to engage a non-intact device for explant. Medical judgement is required for determining the appropriate surgical method for explant in such cases. -Records: For each patient with an affected Superion IDS, append their medical record with a copy of this letter to maintain awareness of this topic for the remaining service life of the device. Should any revision/replacement occur, please inform Boston Scientific with relevant clinical information. For additional information or questions - contact the local Boston Scientific representative, or the Firm's Public Contact, Director, Global Corporate Communications at 415-730-2310 or [email protected].

Recall details

Recall number
Z-0230-2023
Status
Open, Classified
Initiated by the company
Oct 12, 2022
Posted by the FDA
Nov 14, 2022
Recalling firm
Boston Scientific Neuromodulation Corporation
Quantity
175 devices
Product code
NQO
FDA submissions
P140004
Distribution
U.S Nationwide Distribution including states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MI, MN, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, WI, WV, and WY

Product description

Superion Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm

Code information (models, lots, serial numbers)

Model (UPN): 101-9808 UDI-DI (GTIN) Code: 00884662000529 Lot/Batch Numbers: 26176977 Model (UPN): 101-9812 UDI-DI (GTIN) Code: 00884662000543 Lot/Batch Numbers: 26573432 26375758 26815560 26807662 26654632 26928168 26929605 26489700 Model (UPN): 101-9814 UDI-DI (GTIN) Code: 00884662000550 Lot/Batch Numbers: 26366842 26848047 26619510 26323984 26406210 26799951

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under P140004 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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