External Manufacturer
FDA adverse event reports naming External Manufacturer as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: EXTERNAL MANUFACTURER.
- Total reports
- 1,717
- Deaths
- 6
- Injuries
- 951
- Malfunctions
- 760
Reports per year
307
1208
5310
11711
9312
9913
9014
8915
28816
53817
33518
Source: FDA adverse event reports by year received, 2007–2018. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implantable Cardioverter Defibrillator (Non-Crt)LWS1,372
- Programmer, PacemakerKRG136
- Pacemaker/Icd/Crt Non-Implanted ComponentsOSR62
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN38
- Wire, Guide, CatheterDQX31
- Catheter, PercutaneousDQY21
- Electrode, Pacing And Cardioversion, Temporary, EpicardialNHW21
- Introducer, CatheterDYB16
- Permanent Pacemaker ElectrodeDTB7
- Pacemaker Lead AdaptorDTD2
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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