FDA Medical devices recall ·
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps… recall
- Recall number
- Z-0772-2025
- Date
- (initiated November 21, 2024)
- Company / brand
- Medtronic Neuromodulation
7000 Central Ave Ne, Minneapolis, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 59 systems
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Software issues were identified in application version 2.x.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
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
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0772-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.