FDA DevicesClass II
Swan-Ganz Pacing Catheter, Models: D200F7;
Published: May 27, 2026Recall ID: Z-2204-2026Category: devicesCountry: US
Reason for Recall / Hazard
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Product Description & Identification
Swan-Ganz Pacing Catheter, Models: D200F7;
Additional Source Details
| Field | Value |
|---|---|
| City | Irvine |
| State | CA |
| Event id | 98603 |
| Address 1 | 17200 Laguna Canyon Rd |
| Code info | Model-UDI-DI/Lot(Expiration): D200F7-00690103147315/66725358(7/2/2027) |
| Postal code | 92618-5403 |
| Report date | 20260527 |
| Product type | Devices |
| Product quantity | 53 |
| Reason for recall | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260408 |
| Center classification date | 20260515 |
Overview
- Recalling FirmBecton, Dickinson and Company
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada.