MEDLINE 81472RHRecalls & reported problems
Medline Industries, Inc. · SJM INQUIRY CATH STRBL MD 4POLE 2/5/2 5F · Class 2
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.
1 other recall cover devices cleared under the same FDA submission (K242225); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jul 31, 2025Open, Classified
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Z-2612-2025 · Root cause: Under Investigation by firm · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K242225. One submission often covers many models, so check the product and lot details in each record.
- Z-1320-2026 · Dec 22, 2025 · Open, ClassifiedReprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Cat
Other Catheter, recording, electrode, reprocessed devices
- MEDLINE 401904RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed3 recalls1 report
- MEDLINE 401582RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed3 recalls0 reports
- MEDLINE 401474RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls1 report
- MEDLINE 81102RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE BD710FJ282RRHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE BD710DF282RRHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE 401448RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE 401222RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.