Impella RP with SmartAssist; Product Number: 0046-0035;

Summary

The FDA issued a Class I for Impella RP with SmartAssist; Product Number: 0046-0035; by Abiomed, Inc.. Reason: Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR).

Details

Product Description

Impella RP with SmartAssist; Product Number: 0046-0035;

Lot/Code Info: Product Number: 0046-0035; UDI-DI: 00813502011869; Serial Numbers: 492884, 492882, 492883, 522056, 522054, 522055, 522106, 522107, 522110, 522111, 522105, 522109, 520014, 520017, 520018, 520019, 520020, 520021, 520022, 520023, 520747, 520748, 520743, 520744, 520746, 520739, 520740, 520664, 520742, 520660, 520661, 520663, 520666, 520668, 518497, 520659, 520665, 518500, 518501, 518496, 518494, 518499, 518502, 518503, 518963, 518960, 518961, 518962, 518959, 518958, 518955, 518956, 507392, 518954, 507386, 507389, 507390, 507391, 507385, 507384, 507393, 492683, 492682, 492681, 492680, 489923, 489921, 489919, 489918, 489916, 489917, 489915, 492677, 492679, 492674, 509155, 509156, 509157, 509151, 509154, 509149, 491454, 509148, 509150, 491456, 491457, 491458, 491455, 491460, 491461, 491462, 491463, 486724, 486717, 486718, 486721, 476036, 476038, 476034, 476035, 476033, 476032, 476031, 489894, 489892, 489893, 489889, 491433, 491437, 489886, 489887, 489888, 491431, 491432, 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Quantity Affected: 1,560 units

Reason for Recall

Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-12-12

Company