POWERWAND XL 3Fr x 6cmRecalls & reported problems
Icu Medical, Inc. · The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10859821006107), received between May 18, 2018 and May 18, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2018Break
A PATIENT AT THE (B)(6) MEDICAL CENTER LOCATED AT (B)(6) EXPERIENCED AN ADVERSE EVENT THAT INVOLVED ACCESS SCIENTIFIC, LLC'S PRODUCT, THE POWERWAND XL INTRODUCER WITH AN EXTENDED DWELL CATHETER, MODEL 3FR 6 CM, CATALOG NUMBER 94122. THE DETAILS OF THE EVENT IS DESCRIBED AS FOLLOWS, THE HOSPITAL PICC TEAM WAS NOTIFIED THAT THE DEVICE (CATHETER) BROKE AND REMNANTS OF THE DEVICE (CATHETER) REMAINED IN THE PATIENT'S ARM. THE PATIENT REPORTED THAT THE BREAKAGE OCCURED WHILE THE PATIENT WAS TAKING A SHOWER. THE PATIENT REPORTED HAVING A GEL SUBSTANCE IN HER HAIR FROM A PREVIOUS PROCEDURE THAT OF WHICH SHE WAS TRYING TO REMOVE IN THE SHOWER. WHILE IN THE SHOWER, THE DEVICE (CATHETER) WAS WRAPPED IN AQUA GUARD. WHILE THE PATIENT WAS REMOVING THE GEL SUBSTANCE FROM HER HAIR, THE DEVICE (CATHETER) WAS CAUGHT IN HER HAIR AND THE DEVICE (CATHETER) BROKE APART. IMMEDIATELY AFTER THE INCIDENT HAD OCCURED, THE HOSPITAL'S PICC NURSE EVALUATED THE ARM VIA ULTRASOUND METHOD AND DETERMINED THAT 6 CM OF THE DEVICE (CATHETER) REMAINED SUPERFICIAL IN THE EXPECTED LOCATION WITHIN THE FOREARM. AFTER COLLABORATION FROM PHYSICIANS, THE DEVICE (CATHETER) REMNANTS WERE REMOVED FROM THE PATIENT'S ARM USING LOC
Patient problems: No Code Available
MAUDE report 7526476 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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