TEMPO 451418S0Recalls & reported problems
Cordis Corporation · CATH TEMPO 4F USL 2 80CM · 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 10705032007887), received between Dec 7, 2020 and Mar 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Crack1
- Detachment of Device or Device Component1
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.
MalfunctionMar 11, 2024Crack; Crack
AS REPORTED A 4F 80CM UNISELECT (USL) 2 TEMPO DIAGNOSTIC CATHETER STARTED TO FALL APART AT THE HUB. THE CATHETER LOOKED LIKE IT WAS DISINTEGRATED AROUND THE HUB. IT APPEARED DRY, ROTTED, AND SPLINTERED. THERE WERE NO REPORTS OF PATIENT INJURY. THE IR LAB WAS USING THE CATHETER FOR A "Y90 PRODUCER". A CONTRALATERAL APPROACH WAS NOT USED. THERE WAS ACUTE ANGULATION AND BIFURCATION OF THE TARGET SITE VESSEL. THERE WAS ALSO BIFURCATION OF THE ACCESS SITE VESSEL. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB AND BODY OF THE CATHETER. THE DEVICE WAS TORQUED OR ¿STEERED¿ BY THE HUB. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PER PRODUCT ANALYSIS, THE BODY/SHAFT PRESENTED A CRACKED CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18876248 ↗MalfunctionDec 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE TIP OF A 4F 80CM UNI SELECT I (USL) TEMPO CATHETER SNAPPED OFF INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10960458 ↗
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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.
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