Abiomed, Inc.: Impella RP with SmartAssist; Product Number: 0046-0035;

Hazard

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.

Details from the source

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. Distribution: Domestic: Nationwide Distribution International: Canada Quantity: 1,560 units 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, 491436, 484301, 491435, 484300, 483987, 483986, 483984, 483985, 483979, 483981, 483988, 484302, 484294, 484295, 484296, 484298, 486727, 486725, 486726, 486729, 486728, 486732, 486733, 486734, 469495, 469494, 469492, 469493, 469497, 469496, 469488, 469489, 469490, 469491, 476257, 484772, 472427, 472429, 476254, 484773, 484774, 484775, 472430, 476253, 476255, 476250, 476256, 484769, 484771, 467632, 472081, 476259, 472073, 472074, 476251, 476258, 484767, 472075, 472077, 472076, 472078, 472079, 472432, 484776, 471719, 4

UPC codes

00813502011869

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.