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Na 7007

by Boston Scientific GUDID

Listed FDA GUDID listing, no authorization on record Open recall

Regulatory status

as of 29 Oct 2026

Recall ongoing. 3 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00802526474828 UDI-DIDate24 Sep 2014ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2325-2025 FDA Class I initiated 24 Jul 2025 on shared PMA P910073
    • Ongoing Z-2327-2025 FDA Class I initiated 24 Jul 2025
    • Ongoing Z-2326-2025 FDA Class I initiated 24 Jul 2025

    Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

GUDID

Generic Name
Pacing/defibrillation lead cap
Model / Reference
7007
Primary DI / UDI-DI
00802526474828
PMA Number
FDA Product Code
NVY
GMDN Term
Pacing/defibrillation lead cap
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pacing/defibrillation lead cap

Cleared under the same submission (P910073)

Show all (12)

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No