Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported October 26, 2016
Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various
Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Vascular Solutions, Inc. recalled Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethyle… - a critical-severity action.
Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethyle… was recalled by Vascular Solutions, Inc. in October 26, 2016. Reason: Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manu…. Check the official notice for the remedy. Verify recall #Z-0054-2017 with the FDA Devices before acting.
The recall
Vascular Solutions, Inc. issued this critical-severity FDA Devices recall-Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manu….
- Critical
- severity level
- 12K units
- affected scope
- Class I
- classification
- October 26, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0054-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0054-2017) was formally reported on October 26, 2016, with the manufacturer initiating the action on September 16, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. Vascular Solutions, Inc. is listed as the recalling firm, operating out of Maple Grove, MN. Federal records list the affected scope as 11,670 units total.
The documented reason for this recall is: Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lum… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) including Puerto Rico and outside the US to include: Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hu…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
11,670 units total
Related Recalls
6
3 from same agency
Product description
Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters. Model 5200 also has hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a marker band located 1mm from the distal tip. Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.
Reason for recall
Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0054-2017 |
| Date reported | October 26, 2016 |
| Date initiated | September 16, 2016 |
| Recalling firm | Vascular Solutions, Inc. |
| Firm location | Maple Grove, MN |
| Affected scope | 11,670 units total |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico and outside the US to include: Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Isra… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0054-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters. Model 5200 also has hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a marker band located 1mm from the distal tip. Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.. Recalled by Vascular Solutions, Inc.. Units affected: 11,670 units total.
Why was this product recalled? ▼
Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2016. Severity: Critical. Recall number: Z-0054-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico and outside the US to include: Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0054-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 26, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.