SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 00643169890961; Serial Numbers: NPL1000442 NPL1000448 NPL1000453 NPL1000765 NPL1000776 NPL1000797 NPL1000809 NPL1000810 NPL1000811 NPL1000813 NPL1000814 NPL1000815 NPL1000817 NPL1000818 NPL1000819 NPL1000827 NPL1000830 NPL1000834 NPL1000835 NPL1000858 NPL1001552 NPL1001558 NPL1001564 NPL1001566 NPL1001574 NPL1001583 NPL1001590 NPL1001591 NPL1001592 NPL1001594 NPL1001595 NPL1001601 NPL1001608 NPL1001615 NPL1001620 NPL1001629 NPL1001630 NPL1001631 NPL1001650 NPL1001651 NPL1001656 NPL1001670 NPL1001675 NPL1002257 NPL1002259 NPL1002260 NPL1002264 NPL1002265 NPL1002266 NPL1002267 NPL1002281 NPL1002282 NPL1002284 NPL1002286 NPL1002288 NPL1002295 NPL1002297 NPL1002308 NPL1002309
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Neuromodulation
- Reason for Recall:
- Software issues were identified in application version 2.x.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
Product Codes/Lot Numbers:
GTIN: 00643169890961; Serial Numbers: NPL1000442 NPL1000448 NPL1000453 NPL1000765 NPL1000776 NPL1000797 NPL1000809 NPL1000810 NPL1000811 NPL1000813 NPL1000814 NPL1000815 NPL1000817 NPL1000818 NPL1000819 NPL1000827 NPL1000830 NPL1000834 NPL1000835 NPL1000858 NPL1001552 NPL1001558 NPL1001564 NPL1001566 NPL1001574 NPL1001583 NPL1001590 NPL1001591 NPL1001592 NPL1001594 NPL1001595 NPL1001601 NPL1001608 NPL1001615 NPL1001620 NPL1001629 NPL1001630 NPL1001631 NPL1001650 NPL1001651 NPL1001656 NPL1001670 NPL1001675 NPL1002257 NPL1002259 NPL1002260 NPL1002264 NPL1002265 NPL1002266 NPL1002267 NPL1002281 NPL1002282 NPL1002284 NPL1002286 NPL1002288 NPL1002295 NPL1002297 NPL1002308 NPL1002309
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0772-2025
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