TEMPO 451401V5Recalls & reported problems
Cordis Corporation · CATH TEMPO 4F STR 65CM 5SH · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032007641), received between Nov 10, 2025 and Nov 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Degraded” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Degraded2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2025Degraded; Degraded
AS REPORTED, THE BODY OF A 5F TEMPO ANGIOGRAPHIC CATHETERS WAS PEELING OFF, APPEARING AS THOUGH IT WAS DECOMPOSING. THERE WAS NO REPORTED PATIENT INJURY. IT WAS FURTHER REPORTED THAT ADDITIONAL DEVICES FROM THE SAME LOTS AND SKUS EXHIBITED SIMILAR PEELING, WITH APPROXIMATELY NINETEEN DEVICES AFFECTED. IT WAS CONFIRMED THAT THE REMAINING DEVICES WERE STERILE AND EXHIBITED THE SAME FAILURE. DEVICES ARE STORED IN THE WAREHOUSE ALONG WITH OTHER MEDICAL DEVICES. OZONE IS NOT USED TO DISINFECT, AND IT IS NOT USED IN ANY AREAS SUCH AS PROCEDURE OR STORAGE ROOMS. FOUR IMAGES WERE PROVIDED, SHOWING BLUE FLAKES ON A BLOOD-SOAKED SURGICAL TOWEL, CRACKS ON THE CATHETER BODY AND STRAIN RELIEF, AND YELLOWISH DISCOLORATION TO THE HUB. THE DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509151 ↗MalfunctionNov 10, 2025Degraded; Degraded
STERILE DEVICE WAS RECEIVED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509089 ↗
Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices
- TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator 466P306AUCordis Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC6 deaths186 reports
- Dragonfly™ OPTIS™ C408646Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 deaths150 reports
- Dragonfly OpStar™ 1014651Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall87 reports
- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page