Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 31, 2016
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a de…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cook Inc. recalled Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for tr… - a moderate-severity action.
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for tr… was recalled by Cook Inc. in August 31, 2016. Reason: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. …. Check the official notice for the remedy. Verify recall #Z-2616-2016 with the FDA Devices before acting.
The recall
Cook Inc. issued this moderate-severity FDA Devices recall-Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. ….
- Moderate
- severity level
- 13K units
- affected scope
- Class II
- classification
- August 31, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2616-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2616-2016) was formally reported on August 31, 2016, with the manufacturer initiating the action on April 15, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Cook Inc. is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 12,595.
The documented reason for this recall is: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical interven… Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Can…. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
12,595
Related Recalls
6
3 from same agency
Product description
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
Reason for recall
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2616-2016 |
| Date reported | August 31, 2016 |
| Date initiated | April 15, 2016 |
| Recalling firm | Cook Inc. |
| Firm location | Bloomington, IN |
| Affected scope | 12,595 |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, … |
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-2616-2016) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.. Recalled by Cook Inc.. Units affected: 12,595.
Why was this product recalled? ▼
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2016. Severity: Moderate. Recall number: Z-2616-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2616-2016) 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 August 31, 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.