Home › TELEFLEX INCORPORATED › ARROW
ARROW
TELEFLEX INCORPORATED · Model IPN039789 · UDI-DI 10801902145755
DSP
Prescription
10
510(k) clearances
67,887
Adverse events (1,470 deaths)
194
Recalls
28
Facilities
Description
Ultra 8(R) IAB
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-06 | Datascope Corp. | The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has |
| 2026-01-23 | Datascope Corp. | The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated. |
| 2026-01-23 | Datascope Corp. | The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated. |
| 2025-11-04 | Datascope Corp. | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. |
| 2025-11-04 | Datascope Corp. | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. |
| 2025-10-23 | Datascope Corp. | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. |
| 2025-10-23 | Datascope Corp. | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. |
| 2025-07-19 | Insightra Medical Inc | Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not con |
| 2024-09-17 | Datascope Corp. | There is discrepant labeling on the inner and outer packaging of the device. |
| 2024-08-08 | Datascope Corp. | Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clin |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.