Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse… — Class II medical device recall Z-0965-2013
Terminated recall by Boston Scientific CRM Corp, reported 2013-03-27, distributed in AZ, CA, CO, DC, GA, IL, MA, MD…. An internal protective fuse can be unintentionally activated while the device is charging its capacitors for s
| Recall number | Z-0965-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific CRM Corp, Saint Paul, MN, United States |
| Recall initiated | 2013-03-01 |
| Classified | 2013-03-18 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2013-05-23 |
| Distributed | AZ, CA, CO, DC, GA, IL, MA, MD, MN, NC, NJ, NY, OH, PA, SC, VA, WA |
| Countries outside the US | AT, BE, CA, CH, CZ, DE, DK, ES, FR, GB, IE, IT, NL, NZ, PT, SE, SK |
| Serial numbers | 292-887, 297-899, 300-895, A001004, A001005, A001010, A001011, A001012, A001014, A001015, A001020, A001021, A001022, A001023, A001040, A001042, A001051, A001052, A001053, A001055, A001058, A001062, A001063, A001085, A001089 and 475 more |
| Model numbers | 1010 |
Product
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
Reason for recall
An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0965-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.