Twin-Pass® 023" dual access catheter 5230Recalls & reported problems
Vascular Solutions, Inc. · The Twin-Pass catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, and for use during two guidewire procedures. The Twin-Pass .023” catheters are also used to sub selectively infuse/deliver diagnostic or therapeutic agents and to measure intra-arterial pressure within the peripheral vasculature. · Class 2
Data updated Oct 18, 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 M20652300), received between Nov 29, 2017 and Nov 29, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).
1 other recall cover devices cleared under the same FDA submission (K062877); they may or may not involve this specific model.
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
- Detachment Of Device Component1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 29, 2017Detachment Of Device Component; Detachment Of Device Component
PHYSICIAN USED TWINPASS IN CTO CASE, PART OF DISTAL TIP OF TWINPASS BROKE OFF AND STUCK ON WIRE. THE TWINPASS TIP BROKE AS THEY WERE ADVANCING IT ONTO THE WIRE, IT NEVER WENT INTO THE PATIENT. THE PIECE OF THE TIP GOT THROWN AWAY. THE CATHETER WAS NOT TORQUED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7068302 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K062877. One submission often covers many models, so check the product and lot details in each record.
- Z-0055-2017 · Sep 16, 2016 · TerminatedVascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use
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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 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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