ARROW IPN000098Recalls & reported problems
Teleflex Incorporated · CATH PKGD: THERMISTOR 5 80CM · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902004550), received between Nov 4, 2019 and Nov 4, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING INCOMING INSPECTION/INVENTORY REVIEW THAT THE PACKAGING WAS FOUND TO BE INCORRECT. THE CUSTOMER NOTED THAT THE PACKAGING ON THE THERMODILUTION BALLOON CATHETER HAD A RED PACKAGING VS. BLUE PACKAGING. THE LABEL AND THE CATHETER WERE CORRECT BUT THE POUCH WAS INCORRECT. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR CONSEQUENCE.
Patient problems: No Patient Involvement
MAUDE report 9273065 ↗
Other CATHETER, FLOW DIRECTED devices
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- SWAN-GANZ CCOMBO V 777F8Edwards Lifesciences LLC · CATHETER, FLOW DIRECTED2 recalls92 reports
- Graftmaster 1012581-16Abbott Vascular Inc. · CATHETER, FLOW DIRECTED21 deaths147 reports
- SWAN-GANZ CCOMBO V 774F75Edwards Lifesciences LLC · CATHETER, FLOW DIRECTED2 recalls2 deaths41 reports
- Graftmaster 1012581-19Abbott Vascular Inc. · CATHETER, FLOW DIRECTED12 deaths135 reports
- Graftmaster 1012582-19Abbott Vascular Inc. · CATHETER, FLOW DIRECTED13 deaths77 reports
- SWAN-GANZ VIP 831F75Edwards Lifesciences LLC · CATHETER, FLOW DIRECTED1 recall23 reports
- Graftmaster 1012580-26Abbott Vascular Inc. · CATHETER, FLOW DIRECTED13 deaths72 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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