Covidien Newport HT70 and HT70Plus Ventilators Capacitor Failure Recall
Covidien is recalling Newport HT70 and HT70Plus ventilators due to capacitor failures that may cause the device to shut down unexpectedly or fail to alarm, risking respiratory failure and oxygen deprivation in patients.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a critical life-support medical device. Capacitor failures could cause unexpected device shutdown or failure of safety alarms during patient ventilation, creating risk of respiratory failure, hypoxia, and death—serious injuries inherent to the hazard even without reported illnesses.
Plain-English summary
Covidien is recalling Newport HT70 and HT70Plus ventilators worldwide, including distribution across numerous US states and countries internationally. The recalled devices contain a printed circuit board assembly with two separate capacitors that may fail during use.
If the capacitors fail, the ventilator may shut down unexpectedly during operation, requiring immediate use of alternate ventilation. Alternatively, the shutdown alert alarm may fail to function properly, preventing caregivers from being alerted to the device failure.
Potential consequences of these failures include respiratory failure, hypoventilation, low oxygen saturation, hypoxia, and delayed treatment. Approximately 4,842 units are affected globally.
Patients and healthcare providers using these ventilators should contact Covidien or consult the product safety notice for further instructions on the recall and any necessary corrective action.
The recalled product
- Product
- Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA…
- Manufacturer
- Covidien
- Affected units
- 4,842
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Serial Numbers: HT70M-JP-NA/00839935008221/N10HT700710132
- N10HT700710135
- N10HT700710136
- N10HT700710159
- N10HT700710161
- N10HT700710162
- N10HT700710163
- N10HT700710164
- N10HT700810194
- N10HT700810199
- N10HT700810202
- N10HT700810204
- N10HT700810205
- N10HT700810206
- N10HT700910223
- N10HT700910227
- N10HT701010279
- N10HT701011015
- N10HT701011016
- N10HT701111044
Distribution
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