MEDLINE 10438577RHRecalls & reported problems
Medline Industries, Inc. · BW SOUNDSTAR ECO CATH 10FR 90CM SIEMENS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Dec 22, 2025Open, Classified
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Z-1324-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Reprocessed intravascular ultrasound catheter devices
- MEDLINE D087031RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls5 reports
- MEDLINE 10135936RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls0 reports
- MEDLINE 10135910RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls0 reports
- NA ACU10135936Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall11 reports
- NA ACU10135910Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall6 reports
- MEDLINE 10439072RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
- MEDLINE 10439011RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
- MEDLINE 10439236RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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