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

FDA device recall Z-0230-2023 · posted 2022-11-14 · Open, Classified

Recall details

Recalling firm

Boston Scientific Neuromodulation Corporation

Reason for recall

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.

Action taken

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: BSCFieldActionCenter@bsci.com 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 jessica.sachariason@bsci.com.

Root cause

Process change control

Status

Open, Classified

Product code

NQO

Quantity affected

175 devices

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

Date initiated

2022-10-12

Date posted

2022-11-14

Location

Valencia, CA