Here are four of the latest recalls and corrections reported to the FDA.
- Dexcom corrects G7 and One + CGM apps over missed sensor failure alerts: Dexcom is issuing a correction for certain versions of its G7 and ONE+ continuous glucose monitoring apps due to a software design error that may fail to alert users of sensor transmitter failure. Users were instructed to update their apps to restore alert functions. No injuries or deaths have been reported.
- Medline recalls kits containing Medtronic DLP Left Heart Vent Catheters over cannula shape: Medline has recalled specific kits containing Medtronic DLP Left Heart Catheters because some of the cannulas may not retain their shape, which could cause abrasion or perforation during cardiopulmonary bypass procedures. Facilities were instructed to quarantine and destroy the affected products. Three injuries have been reported.
- Philips Respironics recalls DreamStation Auto CPAP and Auto BiPAP devices over programming errors: Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices because of a programming error that can result in incorrect therapy modes, limited pressure, unavailable features or improper sensor/humidifier function. Use of the affected devices could cause hypoventilation, disrupted sleep, skin burns and ineffective treatment of sleep apnea. Customers were instructed to continue using the devices until replacements are delivered. Three injuries have been reported.
- Tandem Diabetes Care corrects insulin pumps over risk of faulty speaker wiring: Tandem Diabetes Care is issuing a correction for certain t:slim X2 insulin pumps after identifying a speaker wiring issue that can trigger a Malfunction 26 error, which could stop insulin delivery and disrupt continuous glucose monitoring. Affected users are advised to monitor the device for error and use a backup insulin delivery method while waiting on a software update. Fifty-nine injuries have been reported.
