Swan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
Becton, Dickinson and Company is recalling Swan-Ganz Pacing Catheter Model D200F7 due to a manufacturing defect that may cause the proximal injectate lumen hub to leak or break, potentially leading to infection, medication loss, or blood loss.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a medical device (catheter) with a manufacturing defect that could lead to serious harm (infection, blood loss) without reports of actual illness or injury to date. The potential for serious consequences qualifies it as High severity per the rubric.
Plain-English summary
Becton, Dickinson and Company is recalling Swan-Ganz Pacing Catheter, Model D200F7, distributed worldwide including across the United States and multiple countries. The catheters may leak or break at the blue proximal injectate lumen hub due to manufacturing process and material changes.
This defect may lead to infection, medication loss, and/or blood loss in patients. A total of 53 units have been identified as potentially affected, with the model-specific lot number D200F7-00690103147315, which expires on July 2, 2027.
Patients and healthcare providers who have received or are using these catheters should contact Becton, Dickinson and Company for further information and guidance regarding their specific units.
The recalled product
- Product
- Swan-Ganz Pacing Catheter, Models: D200F7;
- Manufacturer
- Becton, Dickinson and Company
- Affected units
- 53
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 (1)
- Model-UDI-DI/Lot(Expiration): D200F7-00690103147315/66725358(7/2/2027)
Distribution
Part of a larger recall action
This product is one of 3 recalled by Becton, Dickinson and Company 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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