Cook Inc. Recalls Haskal Transjugular Intrahepatic Portal Access Sets
Cook Inc. is recalling Haskal Transjugular Intrahepatic Portal Access Sets due to polymer degradation that can cause catheter tip fracture and separation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (catheter tip fracture/separation) that can lead to significant injury, such as embolization or occlusion of blood flow.
Plain-English summary
Cook Inc. is recalling 12,595 units of the Haskal Transjugular Intrahepatic Portal Access Set, including the introducer and catheter. The device is intended for transjugular liver access in diagnostic and interventional procedures. The recall covers all lots with catalog/product number HTPS-100 and global/order number G36126.
The recall is being issued due to an increase in reports of polymer degradation of the catheter tip, which can result in tip fracture and/or separation. This degradation can lead to loss of device function or the separation of a device segment, potentially requiring medical intervention. Complications from separated segments may include 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 occlude blood flow to end organs.
The affected products were distributed worldwide, including nationwide in the United States and to numerous international locations. Healthcare providers and facilities should stop using the affected devices and contact Cook Inc. for further instructions on the recall.
The recalled product
- Product
- Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheter
- Affected units
- 12,595
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Lots. Catalog/product number
- Global/order number HTPS-100 G36126
Distribution
Part of a larger recall action
This product is one of 14 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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