Smiths Medical Recalls Port-A-Cath Venous Access Systems Due to Sizing Issue
Smiths Medical is voluntarily recalling Port-A-Cath and Port-A-Cath II implantable venous access systems and introducer sets because the introducer sheath opening may be too small for the catheter.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a medical device with a mechanical sizing issue. The source text does not report any injuries, illnesses, or deaths, and the hazard is limited to potential difficulty in device insertion rather than a direct physiological threat like infection or toxicity.
Plain-English summary
Smiths Medical ASD, Inc. is conducting a voluntary recall of PORT-A-CATH and PORT-A-CATH II Implantable Venous and Arterial Access Systems and Introducer Sets. The recall involves 372 units of specific reference numbers (21-8011-24, 21-8052-24, and 21-8053-24) that were distributed worldwide, including in the United States and internationally to Denmark, Belgium, and Canada.
The recall was initiated after Smiths Medical received a small number of customer reports indicating that the introducer sheath and the introducer opening were too small for the width of the catheter when using these sets. This sizing discrepancy could potentially complicate the introduction of the catheter into the subclavian vein.
Healthcare providers and facilities that have received these specific devices should stop using them and contact Smiths Medical for further instructions. Consumers who have had these devices implanted should consult their healthcare provider if they have concerns regarding the device or the procedure.
The recalled product
- Product
- Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH¿ and PORT-A-CATH¿ II implantable…
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 372
Distribution
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD, 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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